By InvitationNot Applicable

Study of Brain Function Evaluation System for Acute and Prolonged Disorders of Consciousness

China500 participantsStarted 2022-04-13

Plain-language summary

The research focuses on establishing a system for detecting loss of consciousness, developing clinical prognostic and awakening-related brain function testing criteria.

Who can participate

Age range

14 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 14-60 years;
. In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;
. Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;
. right-handed；
. The patient's family members signed the informed consent form;

Exclusion criteria

. The history of mental illness and a history of hearing impairment;
. Intracranial arterial clamp, pacemaker and other metal implants;
. During the experiment, sedatives and other drugs that affect the excitability of the cortex;
. The presence of uncontrolled seizures or involuntary movements;
. The history of mental illness and a history of hearing impairment;
. Intracranial arterial clamp, pacemaker and other metal implants;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Coma recovery scale-revised

Timeframe: Within 24 hours of enrollment

Change from the p300 in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Change from resting-state in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Change from TEP in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Change from PCI in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Trial details

NCT IDNCT06097013

SponsorXuanwu Hospital, Beijing

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08

View on ClinicalTrials.gov More Disorder of Consciousness trials

Who can participate

Age range

14 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 14-60 years;
. In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;
. Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;
. right-handed；
. The patient's family members signed the informed consent form;

Exclusion criteria

. The history of mental illness and a history of hearing impairment;
. Intracranial arterial clamp, pacemaker and other metal implants;
. During the experiment, sedatives and other drugs that affect the excitability of the cortex;
. The presence of uncontrolled seizures or involuntary movements;
. The history of mental illness and a history of hearing impairment;
. Intracranial arterial clamp, pacemaker and other metal implants;

What they're measuring

Change from Coma recovery scale-revised

Timeframe: Within 24 hours of enrollment

Change from the p300 in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Change from resting-state in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Change from TEP in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Change from PCI in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment